Transcatheter heart valve replacement systems, heart valve prostheses, and methods for percutaneous heart valve replacement

ABSTRACT

Prosthetic heart valve devices, heart valve replacement systems and associated methods for percutaneous heart valve replacement are disclosed herein. A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable inflow member attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the inflow member and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the inflow member into a deployed configuration that at least partially engages tissue at the native heart valve.

FIELD OF THE INVENTION

The present technology relates generally to heart valve prostheses,transcatheter heart valve replacement systems and associated methods. Inparticular, several embodiments are directed to transcatheter heartvalve systems and devices for percutaneous replacement of heart valves,such as an aortic valve.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atria and right ventricle which supplies thepulmonary circulation, and the left atria and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To insure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atria and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The leaflets move apart from each other to open and allowblood to flow downstream of the valve, and coapt to close and preventbackflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber or structure (e.g., aorta) to occur at the proper flow rate andcause the heart to work harder to pump the blood through the diseasedvalve. Aortic stenosis, for example, can lead to chest pain, fainting,and heart failure. Valvular insufficiency or regurgitation occurs whenthe valve does not close completely, allowing blood to flow backwards,thereby causing the heart to be less efficient. For example, aorticvalvular insufficiency results in blood pooling in the left ventriclewhich must then expand its normal capacity to accommodate the pooledvolume of blood as well as the new blood received in the subsequentcardiac cycle. For this reason the heart muscle must work harder to pumpthe extra volume of blood which causes strain of the heart muscle overtime as well as raises the blood pressure in the heart. A diseased ordamaged valve, which can be congenital, age-related, drug-induced, or insome instances, caused by infection, can result in an enlarged,thickened heart that loses elasticity and efficiency. Other symptoms ofheart valve diseases, such as stenosis and valvular insufficiency, caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Such symptoms can often besevere enough to be debilitating and/or life threatening.

Prosthetic heart valves have been developed for repair and replacementof diseased and/or damaged heart valves. Such valves can bepercutaneously delivered and deployed at the site of the diseased heartvalve through catheter-based systems. Such prosthetic heart valves canbe delivered while in a low-profile or compressed/contracted arrangementso that the prosthetic valves can be contained within a sheath componentof a delivery catheter and advanced through the patient's vasculature.Once positioned at the treatment site, the prosthetic valves can beexpanded to engage tissue at the diseased heart valve region to, forinstance, hold the prosthetic valve in position. While these prostheticvalves offer minimally invasive methods for heart valve repair and/orreplacement, challenges remain to provide prosthetic valves that preventleakage between the implanted prosthetic valve and the surroundingtissue (paravalvular leakage) and for preventing movement and/ormigration of the prosthetic valve that could occur during the cardiaccycle. For example, the repair or replacement of the aortic valve canpresent numerous challenges due to differing anatomies and etiologiespresented by individual patients. The varying shapes, sizes and otherfeatures associated with an abnormal or unhealthy aortic valve canprevent proper alignment of the replacement (e.g., prosthetic) valvewhich can cause leakage, valve impingement or dislodgement of theprosthesis. In a particular example, stenosis of the aortic valve candeform the valvular area which can result in paravalvular leakage aroundan implanted replacement valve. Additional challenges can includeproviding a prosthetic valve that can be adjusted or repositioned duringor after implantation and/or for replacing a previously implantedprosthetic valve.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof are directed to heart valve prostheses and methods ofpercutaneous implantation thereof. The heart valve prostheses have acompressed configuration for delivery via a vasculature or other bodylumens to a native heart valve of a patient and an expandedconfiguration for deployment within the native heart valve. In anembodiment, the heart valve prosthesis may include an expandable framedefining a lumen through which blood may flow, the lumen extending froma first end to a second end thereof, wherein the frame includes aplurality of commissure posts extending from the first end. Theprosthesis may also include an inflow member attached to the pluralityof commissure posts. The inflow member has an upstream portion and adownstream portion and a channel formed in a wall thereof, wherein thechannel extends from at least the downstream portion to the upstreamportion, and wherein an interior of the inflow member is configured tosupport a prosthetic valve. The prosthesis may further include a lockingmechanism secured within the lumen of the expandable frame and a wireoperably coupled to the locking mechanism. The wire may be at leastpartially slideably disposed within the channel of the inflow member andthe locking mechanism may be configured to permit the wire to beadvanced within the channel of the inflow member to thereby transitionthe inflow member into a deployed configuration.

In another embodiment, a system for repair or replacement of a heartvalve may include a prosthetic heart valve and a catheter assemblyconfigured to delivery and deploy the prosthetic heart valve. In someembodiments, the prosthetic heart valve may have an anchoring structureand an inflow member coupled to and extending from the anchoringstructure. The inflow member defines a lumen from an inflow end to anoutflow end thereof. The inflow member may have a channel disposedwithin a wall thereof. The prosthetic heart valve may also include aprosthetic valve component disposed within the lumen of the inflowmember. The prosthetic valve component can be configured to inhibitretrograde blood flow through the lumen. The prosthetic heart valve mayfurther include an elongated stiffening element at least partiallydisposed within the channel of the inflow member to thereby transitionthe inflow member and the prosthetic valve component into a deployedconfiguration, and still further include a reversible ratchetingmechanism secured to the anchoring structure and coupled to thestiffening element. The catheter assembly may include a handle assemblyhaving a first actuator for operating the reversible ratchetingmechanism to advance the stiffening element within the channel of theinflow member. The catheter assembly may also include an engagement tipextending from the handle assembly and configured to operatively engagethe reversible ratcheting mechanism at a proximal end thereof uponactuation of the first actuator.

In yet another aspect, embodiments of the present technology provide amethod of repairing or replacing a heart valve in a patient. In oneembodiment, the method can include positioning a prosthetic device asdescribed herein in a compressed configuration within a heart valveregion of the patient. The method may also include releasing theprosthetic device to at least partially expand such that an inflowmember extends through an annulus of the heart valve. The method mayfurther include at least partially advancing a wire within a channel ofthe inflow member to transition the inflow member into a deployedconfiguration, and locking a position of the wire when the inflow memberis in the deployed configuration.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and aspects of the present technologycan be better understood from the following description of embodimentsand as illustrated in the accompanying drawings. The accompanyingdrawings, which are incorporated herein and form a part of thespecification, further serve to illustrate the principles of the presenttechnology. The components in the drawings are not necessarily to scale.

FIG. 1 is a schematic sectional illustration of a mammalian heart havingnative valve structures.

FIG. 2A is a schematic illustration of an inferior view of an aorticvalve isolated from the surrounding heart structures and showing theannulus and native leaflets.

FIG. 2B is a schematic illustration of an inferior view of a stenoticaortic valve isolated from the surrounding heart structures and showingthe annulus and native leaflets.

FIG. 3 illustrates a cut-away view of a heart showing a partial sideview of a heart valve prosthesis implanted at a native aortic valve inaccordance with an embodiment of the present technology.

FIG. 4 is a side view of a heart valve prosthesis in a deployed orexpanded configuration (e.g., a deployed state) in accordance with anembodiment of the present technology.

FIGS. 5A-5C are perspective side views of portions of a heart valveprosthesis in accordance with various embodiments of the presenttechnology.

FIG. 6A is a perspective view of an inflow member of the heart valveprosthesis of FIG. 4 in accordance with an embodiment of the presenttechnology.

FIG. 6B is a top view of the inflow member of the heart valve prosthesisof FIG. 4 in accordance with an embodiment of the present technology.

FIG. 6C is a side view of an inflow member in a deployed configurationand in accordance with an embodiment of the present technology.

FIG. 7 is an exploded view of a locking mechanism of a heart valveprosthesis in accordance with an embodiment of the present technology.

FIG. 7A is a perspective end view of an engagement tube of FIG. 7 inaccordance with an embodiment of the present technology.

FIGS. 8A-8D are enlarged sectional views of a locking mechanismillustrating portions of a process for engaging the locking mechanism todeploy or retract the inflow member of the heart valve prosthesis ofFIG. 4 in accordance with an embodiment of the present technology.

FIGS. 9A-9C are enlarged sectional views of a heart valve prosthesisillustrating steps of transition between a delivery configuration (e.g.,low-profile or radially compressed state) and the deployed configuration(FIG. 4) in accordance with another embodiment of the presenttechnology.

FIG. 10 is side partial cut-away view of a delivery system in accordancewith an embodiment of the present technology.

FIG. 11A is an enlarged sectional view of the portion A of the deliverysystem shown in FIG. 10 and in accordance with an embodiment of thepresent technology.

FIG. 11B is an enlarged sectional view of the portion B of the deliverysystem shown in FIG. 10 and in accordance with an embodiment of thepresent technology.

FIG. 12 is flow diagram illustrating a method for repairing or replacinga heart valve of a patient in accordance with an embodiment of thepresent technology.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present technology are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician or with respectto a prosthetic heart valve device. For example, “distal” or “distally”are a position distant from or in a direction away from the clinicianwhen referring to delivery procedures or along a vasculature. Likewise,“proximal” and “proximally” are a position near or in a direction towardthe clinician. With respect to a prosthetic heart valve device, theterms “proximal” and “distal” can refer to the location of portions ofthe device with respect to the direction of blood flow. For example,proximal can refer to an upstream position or a position of bloodinflow, and distal can refer to a downstream position or a position ofblood outflow.

The following detailed description is merely exemplary in nature and isnot intended to limit the present technology or the application and usesof the present technology. Although the description of embodimentshereof are in the context of treatment of heart valves and particularlyan aortic valve, the present technology may also be used in any otherbody passageways where it is deemed useful. Furthermore, there is nointention to be bound by any expressed or implied theory presented inthe preceding technical field, background, brief summary or thefollowing detailed description.

Embodiments of the present technology as described herein can becombined in many ways to treat one or more of many valves of the bodyincluding valves of the heart such as the aortic valve. The embodimentsof the present technology can be therapeutically combined with manyknown surgeries and procedures, for example, such embodiments can becombined with known methods of accessing the valves of the heart such asthe aortic valve with antegrade or retrograde approaches, andcombinations thereof.

FIG. 1 is a schematic sectional illustration of a mammalian heart 10that depicts the four heart chambers (right atria RA, right ventricleRV, left atria LA, left ventricle LV) and native valve structures(tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valveAV). FIG. 2A is a schematic illustration of an inferior view of anaortic valve isolated from the surrounding heart structures and showingthe annulus AN and native cusps or leaflets. Referring to FIGS. 1 and 2Atogether, the heart 10 comprises the left atrium LA that receivesoxygenated blood from the lungs via the pulmonary veins. The left atriumLA pumps the oxygenated blood through the mitral valve MV and into theleft ventricle LV during ventricular diastole. The left ventricle LVcontracts during systole and blood flows outwardly through the aorticvalve AV, into the aorta and to the remainder of the body.

In a healthy heart, the cusps (e.g., leaflets) of the aortic valve AVmeet evenly at the free edges or “coapt” to close (FIG. 2A) and preventback flow of blood from the Aorta. Referring to FIG. 2A, the right cuspRC, the left cusp LC and the posterior cusp PC attach to the surroundingwall of the aorta at the sinotubular junction STJ above a fibrous ringof connective tissue called an annulus AN (FIG. 1). The flexible tissueof the aortic cusps (individually identified as RC, LC, and PC) openfreely during left ventricle LV contraction to allow the blood to leavethe heart chamber and be distributed systemically to the body's tissues.In a heart 10 having aortic valve stenosis, the aortic valve AV hasnarrowed causing the cusps (RC, LC, PC) to not sufficiently coapt ormeet thereby forming a gap 12, as shown in FIG. 2B, that allows blood toback flow into the left ventricle LV. As such, aortic stenosis oftenresults in a heart murmur that can be assessed by ultrasound. Typically,stenosis of the aortic valve AV prevents the valve from openingproperly, forcing the heart muscle to work harder to pump blood throughthe valve. This can cause pooling of blood and pressure to build up inthe left ventricle LV, which can thicken the heart muscle. One cause ofvalve stenosis includes progressive calcification of the valve (e.g.,the aortic valve) which causes thickening and hardening of the tissue.Other causes of stenosis can include congenital defects (e.g., bicuspidvalve), results of infections such as rheumatic fever or endocarditis,and age-related hardening of valve tissues.

Embodiments of prosthetic heart valve devices, delivery systems andassociated methods in accordance with the present technology aredescribed in this section with reference to FIGS. 3-12. It will beappreciated that specific elements, substructures, uses, advantages,and/or other aspects of the embodiments described herein and withreference to FIGS. 3-12 can be suitably interchanged, substituted orotherwise configured with one another in accordance with additionalembodiments of the present technology.

Selected Embodiments of Prosthetic Heart Valve Systems and Devices

Provided herein are systems, devices and methods suitable forpercutaneous delivery and implantation of prosthetic heart valves in aheart of a patient. In some embodiments, methods and devices arepresented for the treatment of valve disease by minimally invasiveimplantation of artificial or prosthetic heart valves. For example, aprosthetic heart valve device, in accordance with embodiments describedherein, can be implanted for replacement of a diseased or damaged nativeaortic valve or prior implanted prosthetic aortic valve in a patient,such as in a patient suffering from aortic valve stenosis illustrated inFIG. 2B. In further embodiments, the device is suitable for implantationand replacement of other diseased or damaged heart valves or priorimplanted prosthetic heart valves, such as tricuspid, pulmonary andmitral heart valves. FIG. 3 illustrates a cut-away view of a heart 10showing a partial side view of a heart valve prosthesis or a prostheticheart valve device 100 implanted at a native aortic valve AV inaccordance with an embodiment of the present technology.

FIG. 4 is a side view of the heart valve prosthesis 100 in a radiallyexpanded or deployed configuration (e.g., a deployed state) inaccordance with an embodiment of the present technology. FIGS. 5A-5C areperspective side views of portions of the heart valve prosthesis 100 inaccordance with various embodiments of the present technology. Referringto FIGS. 3-5C together, the heart valve prosthesis 100 includes a frame110 or expandable structural support that includes a generallycylindrically-shaped anchoring structure 120 (e.g., an anchoring stent)that defines a lumen 121 through which blood can flow. As shown in FIGS.4-5C, the anchoring structure 120 has a first end 122 and a second end124 that are oriented along a longitudinal axis L_(A) of the prosthesis100 (FIG. 4). The frame 110 further includes one or more commissureposts 130 extending from the first end 122 and generally in an upstreamdirection from the anchoring structure 120 (e.g., to extend through theaortic valve AV and at least partially within the left ventricle LV).Additionally, the anchoring structure 120 can have a plurality ofcoupling features 125, such as eyelets, around the second end 124 tofacilitate loading, retention and deployment of the prosthesis 100within and from a delivery catheter (not shown) as further describedherein.

Coupled to the commissure posts 130 is an inflow member or component 140that is generally tubular in shape and has an interior 141 forretaining, holding and/or securing a prosthetic valve component 150(shown as dotted lines in FIG. 4) therein. In embodiments in accordanceherewith, and as explained in considerable detail below, the inflowmember 140 may be radially expanded or collapsed in a manner similar toa tent, i.e., by advancing or positioning a support within the inflowmember 140 or by retracting or removing the support from the inflowmember 140.

As illustrated in FIG. 4, the inflow member 140 has an upstream portion142 at an inflow end 143 that provides an opening to the interior 141,and has a downstream portion 144 at an outflow end 145 that are orientedalong the longitudinal axis L_(A) of the prosthesis 100. Generally, whenimplanted (FIG. 3), the upstream portion 142 of the inflow member 140 isoriented to receive blood inflow from a first heart chamber (e.g., leftventricle, left atrium), and the downstream portion 144 is oriented torelease blood outflow into a second heart structure or chamber (e.g.,aorta or left ventricle). As blood exits the downstream portion 144 ofthe inflow member 140, blood flow continues through the lumen 121 of theanchoring structure 120 and/or through side portals 114 (e.g., removedportions, cut-away portions, etc.) of the prosthesis 100 formed in theinflow member 140 (FIG. 4) and/or at or near the first end 122 of theanchoring structure 120 (FIGS. 5A-5C) to exit the heart 10 via the rightand left coronary arteries CA (FIG. 3).

Referring to FIGS. 4-5C together, the inflow member 140 is reversiblyexpanded or collapsed with one or more elongated stiffening elements orwires 160 (FIGS. 5A-5C) that are at least partially disposed within achannel 146 formed within a wall 147 of the inflow portion 140 (FIG. 4).Accordingly as previously stated, the inflow member 140 is an expandabletube or tent-like structure that can be erected or collapsed byadvancing or retracting the wires 160, respectively. Referring to FIGS.4, 6A and 6B, the inflow member 140 includes a flexible sheet 148 thathas an inner layer 149 a and an opposing outer layer 149 b that sandwichthe wire(s) 160 therebetween at the inflow end 143 and, in oneembodiment, between which the channel 146 can be defined. The flexiblesheet 148 can be a sealing material that provides the inner layer 149 aand/or the outer layer 149 b to prevent leakage of blood (e.g.,paravalvular leakage) between the implanted prosthesis 100 and thenative heart tissue.

In one embodiment, the frame 110 can be a flexible metal frame orsupport structure having a plurality of ribs and/or struts 116geometrically arranged to provide a latticework capable of beingradially compressed (e.g., in a delivery state, not shown) for deliveryto a target native valve site, and capable of radially expanding (e.g.,to the radially expanded configuration shown in FIGS. 4-5C) fordeployment and implantation at the target native valve site. Referringto the anchoring structure 120 shown in FIGS. 4-5C, the struts 116 canbe arranged in a plurality of geometrical patterns that can expand orflex and contract while providing sufficient resilience and strength formaintaining position of the prosthetic 100 with respect to the nativeanatomy of the heart. For example, the struts 116 can be arranged in acircumferential pattern about the longitudinal axis L_(A), wherein thecircumferential pattern includes a series of diamond, zig-zagged,sinusoidal, or other geometric shapes.

In some embodiments described herein, and in order to transform orself-expand between an initial compressed configuration (e.g., in adelivery state, not shown) and the deployed configuration (FIG. 4), theframe 110 is formed from a resilient or shape memory material, such as anickel titanium alloy (e.g., nitinol), that has a mechanical memory toreturn to the deployed or expanded configuration. In one embodiment, theframe 110 can be a unitary structure that defines the anchor structure120 and the commissure posts 130 (FIGS. 5A-5C) to which the flexiblesheet 148 and/or wire(s) 160 of the inflow member 140 attach. The frame110 so described may be made from stainless steel, a pseudo-elasticmetal such as nickel titanium alloy or nitinol, or a so-called superalloy, which may have a base metal of nickel, cobalt, chromium, or othermetal. In some arrangements, the frame 110 can be formed as a unitarystructure, for example, from a laser cut, fenestrated, nitinol or othermetal tube. Mechanical memory may be imparted to the structure thatforms the frame 110 by thermal treatment to achieve a spring temper inthe stainless steel, for example, or to set a shape memory in asusceptible metal alloy, such as nitinol. The frame 110 may also includepolymers or combinations of metals, polymers or other materials. In analternative embodiment, the anchoring structure 120 can be aballoon-expandable tubular metal stent.

In other embodiments, the frame 110 can include separately manufacturedcomponents that are coupled, linked, welded, or otherwise mechanicallyattached to one another to form the frame 110. For example, thecommissure posts 130 can be coupled at or near to the first end 122 ofthe anchoring structure 120 (e.g., at attachments points 123 on thestruts 116 as defined by a diamond-shaped geometry of the anchoringstructure 120). In particular embodiments, and as shown in FIG. 4, thecommissure posts 130 and the anchoring structure 120 may be coupled by avariety of methods known in the art, e.g., soldering, welding, bonding,rivets or other fasteners, mechanical interlocking, or any combinationthereof. Other arrangements and attachment points are contemplated forcoupling a locking mechanism 170 and/or slideably coupling the wire(s)160 within the lumen 121 of the anchoring structure 120, as described inmore detail herein.

FIGS. 4-5C show the commissure posts 130 extending from the first end122 of the anchoring structure 120. As illustrated, the commissure posts130 are arranged or spaced relatively evenly about a circumference ofthe anchoring structure 120, and individual commissure posts 130 joinadjacent struts 116 at a tip or crown 117, which in some embodiments canbe the attachment point 123. In one embodiment, the tips 117 can beatraumatic in order to prevent injury to the cardiac tissue duringdeployment and through the cardiac cycle. In other arrangements, thecommissure posts 130 can be unevenly distributed about a circumferenceof the anchoring structure 120.

As illustrated in FIG. 3, the inflow member 140 can engage tissue withinthe left ventricle LV on or above the fibrous annular ring (e.g., aorticannulus) demarking the junction of the aortic valve and the ventricularseptum when implanted within a native aortic valve space. In thisembodiment, the anchoring structure 120 can retain the inflow member 140in a desired position within the native aortic valve and the inflowmember 140 can adjustably expand to provide a desired radial forceagainst native tissue and/or against prior implanted prosthetic surfacesto prevent paravalvular leakage and to retain the prosthetic valvecomponent 150 in a desired position within the native valve region(e.g., between the native cusps and annulus of the aortic valve).

When deployed, the inflow member 140 and anchoring structure 120 areshown having generally circular cross-sectional shapes with the inflowmember 140 having a cross-sectional dimension D₁ that is greater than across-sectional dimension D₂ of the anchoring structure 120 (FIG. 4). Insome embodiments, the inflow member 140, the anchoring structure 120 orboth can have other cross-sectional shapes, such as to accommodatedeformations in the native aortic valve (e.g., bicuspid aortic valve,calcification, thickening, etc.) or the D-shaped mitral valve. Forexample, the inflow member 140 and/or anchoring structure 120 may expandto an irregular, non-cylindrical, or oval-shaped configuration foraccommodating such deformations (e.g., congenital and/or disease-relateddeformations) or for accommodating the mitral valve. Furthermore, thenative valves (e.g., aortic, mitral) can be uniquely sized and/or haveother unique anatomical shapes and features that vary between patients,and the prosthesis 100 for replacing or repairing such valves can besuitable for adapting to the size, geometry and other anatomicalfeatures of such native valves. For example, the inflow member 140 canexpand within the native heart valve region while simultaneously beingflexible so as to conform to the region engaged by the inflow member140.

FIGS. 6A and 6B are a perspective view and a top view, respectively, ofthe inflow member 140 of the prosthesis 100 illustrated in FIG. 4 and inaccordance with an embodiment of the present technology. FIG. 6C is aside view of an inflow member 140 of the prosthesis 100 in accordancewith an additional embodiment of the present technology. As illustratedin FIGS. 4 and 6A-6C, the inflow member 140 has the downstream portion144 and the upstream portion 142 opposite the downstream portion 144relative to the longitudinal axis L_(A) of the prosthesis 100. Theupstream portion 142 of the inflow member 140 can be a generally outwardoriented portion of the prosthesis 100, as shown. In one embodiment, theinflow member 140 has a frusto-conical shape. In another embodiment, thedownstream portion 144 can be substantially circular in cross-sectionwhile the upstream portion 142 can be generally circular ornon-circular. In various arrangements, the cross-sectional shape of theupstream portion 142 can be imparted by the shape of the wire(s) 160(shown in dotted lines in FIGS. 6B and 6C) as described further herein.Optionally, the inflow member 140 can include one or more resilientlydeformable and flexible circumferential ribs 642 which, in someembodiments, can form a zig-zag, diamond or other pattern ring (FIG.6C). The circumferential ribs 642 can provide additional radial force atthe downstream portion 144 of the inflow member 140, and in someinstances, additional support in the region of the inflow member 140supporting the prosthetic valve component 150 therein.

As illustrated in FIG. 6B, the prosthetic valve component 150 may becoupled to the flexible sheet 148 within the interior 141 of the inflowmember 140 for governing blood flow through the heart valve prosthesis100. For example, the prosthetic valve component 150 can include aplurality of leaflets 152 (shown individually as 152 a-c) that coapt andare configured to allow blood flow through the prosthesis 100 in adownstream direction (e.g., from the inflow end 143 of the inflow member140 to the second end 124 of the anchoring structure 120) and inhibitblood flow in an upstream direction (e.g., from the outflow end 145 tothe inflow end 143 of the inflow member 140). While the prosthetic valvecomponent 150 is shown having a tricuspid arrangement, it is understoodthat the prosthetic valve component 150 can have two leaflets 152(bicuspid arrangement, not shown) or more than three leaflets 152 thatcoapt to close the prosthetic valve component 150. In one embodiment,the leaflets 152 can be formed of bovine pericardium or other naturalmaterial (e.g., obtained from heart valves, aortic roots, aortic walls,aortic leaflets, pericardial tissue, such as pericardial patches, bypassgrafts, blood vessels, intestinal submucosal tissue, umbilical tissueand the like from humans or animals) that are mounted to the flexiblesheet 148 within the interior 141 of the radially-expanding inflowmember 140. In another embodiment, synthetic materials suitable for useas valve leaflets 152 include DACRON® polyester (commercially availablefrom Invista North America S.A.R.L. of Wilmington, Del.), other clothmaterials, nylon blends, polymeric materials, and vacuum depositionnitinol fabricated materials. In yet a further embodiment, valveleaflets 152 can be made of an ultra-high molecular weight polyethylenematerial commercially available under the trade designation DYNEEMA fromRoyal DSM of the Netherlands. With certain leaflet materials, it may bedesirable to coat one or both sides of the leaflet with a material thatwill prevent or minimize overgrowth. It can be further desirable thatthe leaflet material is durable and not subject to stretching,deforming, or fatigue.

Referring to FIGS. 4 and 6A-6C together, the flexible sheet 148 can be asheet of flexible material coupled to one or more commissure posts 130.In some embodiments the flexible sheet 148 can be folded flexiblematerial that forms the opposing inner and outer layers 149 a, 149 b ofthe wall 147. In such embodiments, the channel 146 can be formed (e.g.,via stitching, tape, staples, or other securing means) between the innerand outer layers 149 a, 149 b and thereby provide a path through whichthe wire(s) 160 can slideably move. The flexible sheet 148 can preventparavalvular leakage as well as provide a medium for tissue ingrowthfollowing implantation, which can further provide biomechanicalretention of the prosthesis 100 in the desired deployment locationwithin the native heart valve region. In some embodiments, the flexiblesheet 148 or portions thereof may be a low-porosity woven fabric, suchas polyester, DACRON® polyester, or polytetrafluoroethylene (PTFE),which creates a one-way fluid passage when attached to the frame 110(e.g., the commissure posts 130). In one embodiment, the flexible sheet148 or portions thereof may be a looser knit or woven fabric, such as apolyester or PTFE knit, which can be utilized when it is desired toprovide a medium for tissue ingrowth and the ability for the fabric tostretch to conform to a curved surface. In another embodiment, polyestervelour fabrics may alternatively be used for at least portions of theflexible sheet 148, such as when it is desired to provide a medium fortissue ingrowth on one side and a smooth surface on the other side.These and other appropriate cardiovascular fabrics are commerciallyavailable from Bard Peripheral Vascular, Inc. of Tempe, Ariz., forexample. In another embodiment, the flexible sheet 148 or portionsthereof may be a natural graft material, such as pericardium or anothermembranous tissue.

In addition to the inflow member 140 providing flexible material forpreventing paravalvular leakage and/or tissue ingrowth, and inalternative embodiments, other portions of the prosthesis 100, such asthe anchoring structure 120 and/or the commissure posts 130 may also beprovided with a flexible material (not shown) to cover at least portionsof surfaces thereof. Such materials may include those described hereinor other materials that provide sealing, tissue ingrowth, and/orotherwise provide an atraumatic surface to engage native cardiac tissue.

In some embodiments, and as shown in the radially expandedconfigurations of FIGS. 4-5C, the prosthesis 100 also includes a lockingmechanism 170 secured within the lumen 121 of the anchoring structure120 and operably coupled to the wire(s) 160 for permitting the wire(s)to be advanced within the channel 146 (FIG. 4) of the inflow member 140during implantation of the prosthesis 100. It should be understood thatprior to being distally advanced within the channel 146 of inflow member140 that the wire(s) 160 are substantially straight when positionedwithin a delivery system or catheter. The wire(s) 160 take the curvedshapes shown in FIGS. 5A-5C when distally advanced into the channel 146of inflow member 140. In other words, the channel 146 of inflow member140 shapes or curves the wire(s) 160 as shown in FIGS. 5A-5C and theinflow member 140 is not shown in FIGS. 5A-5C for illustrative purposesonly.

Referring to FIG. 5A, a first end 161 of the wire 160 is operablycoupled to an upstream portion 171 of the locking mechanism 170, and thelocking mechanism 170 is configured to permit the wire 160 to beadvanced within the channel 146 (FIG. 4) of the inflow member 140 andthereby transition the inflow member 140 into a deployed configuration.When deployed, the wire 160 or other stiffening element is structurallyindependent of the anchoring structure 120 such that the wire 160 isradially deformable (e.g., for accommodating irregularly-shaped nativeanatomy, accommodating forces during the cardiac cycle, etc.) withoutsubstantially deforming the anchoring structure 120. Additionally,deformation of segments of the wire 160 providing structure at theinflow end is not translated to the downstream portion 144 of the inflowmember 140 or the prosthetic valve component 150 housed therein.

In some embodiments, the wire 160 comprises shape memory material (e.g.,nitinol) that can be pre-set to form a desired shape for radiallyexpanding and providing support to the inflow member 140 when in anunbiased configuration. In another embodiment, the wire 160 can beformed of other metal or polymers or combinations thereof that may havemechanical or shape memory properties. In certain embodiments thewire(s) can be a single stranded wire while in alternative embodiments,the wire(s) 160 can be multi-stranded or braided wire(s). As describedin more detail herein, the embodiments shown in FIGS. 5A and 5Billustrate arrangements of the prosthesis 100 having a single wire 160distally advanceable to expand the inflow member 140 to the deployedconfiguration. FIG. 5C illustrates an arrangement having two wires 160a, 160 b for expanding the inflow member 140 to the deployedconfiguration. Other arrangements can include more than two wires 160.For example, multiple wires can be advanced or retracted to provide thedesired radial strength to the inflow member 140. More than one wire 160can be advanced along the same path through the channel 146 of theflexible sheet 148. In other embodiments, multiple wires 160 can advancealong different portions of the channel 146.

FIG. 5A illustrates an embodiment in which the wire 160 is advanced(e.g., by the locking mechanism 170) axially along a commissure post 130followed by an arched portion 162. Referring to FIGS. 4 and 5A together,when the wire 160 is disposed within the channel 146 formed in theflexible sheet 148 of the inflow member 140 (FIG. 4), the wire 160 isadvanced from the downstream portion 144 within a longitudinal segment442 of the channel 146 to radially expand the arched portion 162 withina circumferential segment 444 of the channel 146 to thereby expand orform the inflow end 143 of the inflow member 140. In the illustratedembodiment, a second end 163 (e.g., distal end) of the wire 160 isadvanced such that the arched portion 162 of the wire 160 forms a loop164. When disposed within the channel 146 of the flexible sheet 148, asshown in FIG. 4, the wire 160 of FIG. 5A would at least partiallysurround an opening 446 of a lumen 448 at the inflow end 143 of theinflow member 140 thereby providing an expandable inlet into theprosthesis 100 and through which blood may flow following implantation.The second end 163 of the wire 160 may be advanced to several positionswithin the channel 146, for example within the circumferential segment444 thereof, until a desired or effective loop radius R_(L) is achieved.For example, a clinician may observe paravalvular leakage duringimplantation and continually and/or incrementally advance (or retract)the second end 163 of the wire 160 until the leakage is ceased.Accordingly, the loop radius R_(L) may be increased or decreased byadvancing or retracting the second end 163 of the wire 160 within thecircumferential segment 444 of the channel 146, thereby providing analterable or customizable component of the prosthesis 100 that canconform to a patient's unique anatomy in real-time during implantation.In certain embodiments, the second end 163 of the wire 160 may includean atraumatic tip 165 or other feature to inhibit penetration of theinner and/or outer layers 149 a, 149 b (FIGS. 6A and 6B) of the flexiblesheet 148, the surrounding cardiac tissue during implantation, and/or toprovide an anchoring point at which the wire can be secured within thechannel 146 following deployment of the inflow member 140.

FIG. 5B illustrates another embodiment in which the first and secondends 161, 163 of the wire 160 are coupled to the locking mechanism 170.In this embodiment, a portion of the wire between the first and secondends 161, 163 is slideably disposed within the longitudinal andcircumferential segments 442, 444 of the channel 146 (FIG. 4) to form aloop 164. In this embodiment, a loop radius R_(L) may be increased ordecreased by extending or retracting either or both of the first andsecond ends 161, 163 with respect to the upstream portion 171 of thelocking mechanism 170. For example, in one embodiment, the second end163 may be in a fixed position with respect to the upstream portion 171and the first end 161 is moveable with respect to the upstream portion171 to thereby increase or decrease the loop radius R_(L) as desired.Likewise, the first end 161 may be in a fixed position and the secondend 163 can be movable. In still other arrangements, the first andsecond ends 161, 163 may move in unison or separately to adjust the loopradius R_(L). In operation, and when disposed within the channel 146 ofthe flexible sheet 148 of the inflow member 140 (FIG. 4), the wire 160can be extended distally from the locking mechanism 170 to increase theloop radius R_(L) within the circumferential segment 444 of the channel146, thereby radially extending the inflow end 143 at the upstreamportion 144 of the inflow member 140.

In yet another embodiment, illustrated in FIG. 5C, the prosthesis 100has first and second wires 160 a, 160 b coupled to the locking mechanism170. In this embodiment, each of the first ends 161 a, 161 b of thewires 160 a, 160 b are coupled to the upstream portion 171 of thelocking mechanism 170, and when disposed within the channel 146 of theflexible sheet 148 (FIG. 4), the second ends 163 a, 163 b of the wires160 a, 160 b would at least partially surround the opening 446 of thelumen 448 at the inflow end 143 of the inflow member 140. Referring toFIGS. 4 and 5C together, the second ends 163 a, 163 b can advance withinthe longitudinal segment 442 of the channel 146 (e.g., as the wires 160a, 160 b advance distally along the commissure post 130), however, thefirst and second wires 160 a, 160 b diverge where the longitudinalsegment 442 junctures with the circumferential segment 444. Moreparticularly, an arched portion 162 a of the first wire 160 a advancesat the juncture in a first direction D_(A) and an arched portion 162 bof the second wire 160 b advances at the juncture in a second directionD_(B). In other words during operation, the first and second wires 160a, 160 b diverge where the longitudinal segment 442 segues to thecircumferential segment 444 of the channel 146 within the flexible sheet148 (FIG. 4). The second end 163 a of the first wire 160 a can beadvanced to a desired first position within the circumferential segment444, and the second end 163 b of the second wire 160 b can be advancedto a second position within the circumferential segment 444. As such,the second ends 163 a, 163 b of the wires 160 a, 160 b may be advancedto multiple first and/or second positions within the channel 146 untilthe desired or effective loop radius R_(L) is achieved. In oneembodiment, the second ends 163 a, 163 b may meet; however in otherembodiments, the second ends 163 a, 163 b may not extend through theentire circumferential segment 444. In still other embodiments, thesecond ends 163 a, 163 b may overlap such that for at least a portion ofthe circumferential segment 444, the wires 160 a, 160 b overlap, forexample to provide additional radial force or resilience within theoverlapped region (not shown).

Referring to FIGS. 5A-5C together, the locking mechanism 170 can be anyoperator-controllable mechanical system that provides for theadvancement or retraction of the wire(s) 160 through the channel 146 ofthe flexible sheet 148 of the inflow member 140. In some instances thelocking mechanism 171 can provide for small incremental movements of thewire(s) 160 within the channel 146. In addition to advancement orretraction of the wire(s), and when deployed within the heart, thelocking mechanism 170 may also be configured to maintain the wire 160 ata desired position within the channel 146 to maintain the inflow member140 at the selected level of expansion, i.e., a desired loop radiusR_(L), within the patient's valvular area. For example, the lockingmechanism 170 can be configured to prevent slippage or retraction of thewire(s) 160 proximally which could collapse the inflow member 140following implantation. In one embodiment, the locking mechanism 170 caninclude a ratcheting mechanism 710 as described in more detail withrespect to FIGS. 7-8D. In alternative arrangements, the lockingmechanism 170 can include a screw or lock screw system. One of ordinaryskill in the art will recognize other mechanical systems for advancingand/or retracting the wire(s) 160 or other elongated stiffening elementsto radially expand and deploy the inflow member 140 during implantation.

FIG. 7 is an exploded view of a ratcheting mechanism 710 for use withthe heart valve prosthesis 100 of FIG. 4 in accordance with anembodiment of the present technology. The ratcheting mechanism 710includes a ratchet member 720 coupled to the wire(s) 160, a ratchethousing 730 at least partially surrounding the ratchet member 720, aratchet tube 740 slideably disposed between the ratchet member 720 andthe ratchet housing 730, and a slotted engagement tube 750 for engagingand moving the ratchet member 720 with respect to the ratchet housing730. The ratchet housing 730 has opposing pawls 732 a, 732 b, 732 c, 732d extending from a distal end 731 thereof. The ratchet member 720includes a plurality of circumferential indentations 722 longitudinallyspaced along a length L₁ of the ratchet member 720. The ratchet housing730 is configured to be secured within the lumen 121 of the anchoringstructure 120 as shown in FIGS. 4 and 5A-5C. In an embodiment hereof,the ratchet housing 730 is positioned along an inner circumference ofthe anchoring structure 120 so as to position the ratcheting mechanism710 out of the blood flow passing through the lumen 121. Thecircumferential indentations 722 are configured to interact with theopposing pawls 732 a, 732 b, 732 c, 732 d of the ratchet housing 730 inorder to permit linear movement of the ratchet member 720 within andrelative to the ratchet housing 730 in only a first direction (e.g.,distally). In this embodiment, the wire 160 is securely coupled theratchet member 720 at a distal portion 721 thereof, and such linearmotion of the ratchet member 720 in the distal direction therebytranslates to distal movement of the wire 160 (e.g., within the channel146; FIG. 4).

FIGS. 8A-8D are enlarged sectional views of the ratcheting mechanism 710of FIG. 7 illustrating portions of a process for engaging the ratchetingmechanism 710 to deploy or retract the inflow member 140 of the heartvalve prosthesis 100 of FIG. 4 in accordance with an embodiment of thepresent technology. FIG. 8A illustrates of a first position of theratcheting mechanism 710 during deployment of the prosthesis 100, andparticularly deployment of the inflow member 140. In this position (andduring percutaneous delivery of the prosthesis 100), the ratchet member720 is disposed within the ratchet housing 730 and tips 734 a, 734 c ofthe opposing pawls 732 a, 732 c are substantially aligned with thedistal portion 721 of the ratchet member 720. It should be understoodfrom the cross-sectional views shown in FIGS. 8A-8D that opposing pawls732 b, 732 d shown in FIG. 7 would also include tips that act in thesame manner as described herein for tips 734 a, 734 c of opposing pawls732 a, 732 c. The wire 160 is secured within a lumen 726 of the ratchetmember 720 and extends distally beyond the distal portion 721 thereof.In various arrangements, the wire 160 may be secured within the lumen726 via adhesive, compression fit, or other mechanical means such aslocking pin or screw.

A slotted tip 751 of the engagement tube 750, shown enlarged in FIG. 7A,has opposing longitudinal slots 753 a, 753 b between which extendopposing engagement levers 752 a, 752 b that are seated within aproximalmost indentation 724 within a proximal portion 725 of theratchet member 720. When not contained or biased inward by ratchet tube740, each of the opposing engagement levers 752 a, 752 b may beconfigured to spread apart from the corresponding opposing lever and ina radially outward position so as to facilitate release of the ratchetmember 720 when deployment is complete (described in more detail withrespect to FIG. 8C). In the illustrated embodiment, the ratchet tube 740is configured to surround the engagement tube 750 to maintain engagementof the opposing engagement levers 752 a, 752 b with the indentation 724by restraining the opposing engagement levers 752 a, 752 b in aradially-inward or compressed orientation (see FIGS. 8A-8B, forexample).

Referring to FIG. 8B, the wire 160 is advanced distally through distalmovement (arrow A₁) of the ratchet member 720 with respect to theratchet housing 730. Operatively, the engagement tube 750 is translateddistally (e.g., by control through a deployment catheter describedfurther herein) which pushes the ratchet member 720 in a forward ordistal direction (arrow A₁). The opposing pawls 732 a, 732 b, 732 c, 732d of the ratchet housing engage sequential circumferential indentations722 (shown individually in FIG. 8B as 722 a-722 e) thereby permittinglinear movement of the ratchet member 720 in the distal direction (arrowA₁) and inhibiting linear movement proximally. While fivecircumferential indentations 722 on the ratchet member 720 areillustrated in FIGS. 8A-8D, one of ordinary skill in the art willrecognize that more than five indentations 722 or less than fiveindentions are possible. Likewise the ratchet member may have the lengthL₁ (FIG. 7) of any suitable length for translating distal movement tothe wire(s) 160 as desired to deploy the inflow member 140 (FIG. 4).Furthermore, while four opposing pawls 732 a, 732 b, 732 c, 732 d on theratchet housing 730 are illustrated, one of ordinary skill in the artwill recognize that the ratchet housing 730 is not limited to fouropposing pawls and that that the ratchet housing can have any number ofpawls (e.g., greater or lesser than four) circumferentially positionedabout the distal end 731 of the ratchet housing 730 without departingfrom the scope hereof.

Upon full deployment of the inflow member 140 (FIG. 4), the ratchetmechanism 710 can be disengaged by the delivery catheter system (notshown) in a manner that allows the ratchet member 720 to be maintained(e.g., locked) at a desired position with respect to the ratchet housing730 and while preventing slippage or retraction of the wire(s) 160proximally. Referring to FIG. 8C, once the desired positioning of thewire(s) 160 is achieved, the ratchet tube 740 can be retractedproximally (arrow A₂) relative to the proximal portion 725 of theratchet member 720 thereby allowing the opposing engagement levers 752a, 752 b of the engagement tube 750 to return to their unbiased position(e.g., radially outward from the indentation 724 of the ratchet member720). Upon release of the opposing engagement levers 752 a, 752 b of theengagement tube 750, the engagement tip can be disengaged from theratchet member 720 and retracted proximally (arrow A₃). Once the ratchettube 740 and the engagement tube 750 are disengaged from the prosthesis100, the ratchet mechanism 710 is in a locked configuration (FIG. 8C)and remains so in vivo.

In certain instances, it may be desirable to adjust the positioning ofthe prosthesis 100 within the native anatomy during implantation and/orafter implantation. For example, cardiac imaging (e.g.,echocardiography, fluoroscopy, etc.) can be used to assess positioningand outcome (e.g., prevention of paravalvular leakage) of the implantedprosthesis 100 (FIG. 3), and such imaging tools can instruct cliniciansto reposition the device and/or adjust the degree of inflow member 140expansion for achieving effective implantation. Likewise, it may bedesirable to remove and/or replace the prosthesis 100 after implantationand/or use thereof. Accordingly, the ratcheting mechanism 710 allows forre-engagement of the locked position either before or after full removalof the ratchet tube 740 and engagement tube 750 components. FIG. 8Dillustrates a step in a repositioning process of the ratchetingmechanism 710 in accordance with one embodiment of the presenttechnology.

Referring to FIG. 8D, the engagement tube 750 is positioned with respectto the ratchet member 720 such that the opposing engagement levers 752a, 752 b are aligned with the proximalmost indentation 724 and such thatthe ratchet tube 740 compresses the levers 752 a, 752 b to engage theindentation 724 as it is slideably moved distally (arrow A4). Theratchet tube 740 is shown slideably disposed between the ratchet housing730 and the ratchet member 720 so as to disengage and/or inhibitengagement of the opposing pawls 732 a, 732 b, 732 c, 732 d with thecircumferential indentations 722 of the ratchet member 720. In instancesof repositioning the prosthesis 100, the ratchet tube 740 can lift ordisengage the opposing pawls 732 a, 732 b, 732 c, 732 d from thecircumferential indentation 722 b previously engaged. Upon disengagementof the opposing pawls 732 a, 732 b, 732 c, 732 d of the ratchet housing730, the ratchet member 720 can be retracted proximally (arrow A5) byoperatively retracting the engagement tube 750, thereby retracting thewire(s) 160 and at least partially collapsing the inflow member 140 forrepositioning and/or removal of the prosthesis 100 as described.

Referring to FIGS. 3-8D together, the prosthesis 100 is provided withmeans to adjust the radial force of the inflow member 140 using one ormore wires 160 to incrementally and selectively expand the inflow member140 to accommodate unique patient anatomy during implantation.Additionally, the locking mechanism 170 configured for use with theprosthesis to manipulate the wire(s) 160, can allow a clinician toreposition the inflow member 140 and/or the prosthesis 100 multipletimes within the native valve until a desired position and level ofexpansion (e.g., of the inflow member 140) is achieved (e.g., to reduceinstances of paravalvular leakage). Furthermore, and as described inmore detail herein, the cross-sectional profile of the inflow member 140in a delivery configuration can be relatively reduced when compared toconventional prosthetic implants, thereby facilitating delivery of theprosthesis 100 percutaneously. For example, the wire 160 is used toexpand the inflow member 140 only after locating the prosthesis fordeployment within the targeted native region of the heart, whichcontributes to the reduced cross-sectional profile during delivery.

Selected Systems and Methods for Delivery and Implantation of ProstheticHeart Valve Devices

Several suitable delivery and deployment methods are discussed hereinand discussed further below; however, one of ordinary skill in the artwill recognize a plurality of methods suitable to deliver the prosthesis100 to the targeted native valve region (e.g., percutaneous,transcatheter delivery using retrograde or antegrade approaches).Additionally, one of ordinary skill in the art will recognize aplurality of methods suitable to deploy the prosthesis 100 from acompressed configuration for delivery to the expanded configurationillustrated in FIG. 4.

FIGS. 9A-9C are enlarged sectional views of a heart valve prosthesis 100illustrating steps of transition between a delivery configuration (e.g.,low-profile or radially compressed state) and the deployed or expandedconfiguration (FIG. 4) in accordance with another embodiment of thepresent technology. The heart valve prosthesis 100 can be movablebetween a compressed configuration (FIG. 9A) and an expandedconfiguration (FIG. 4) for deployment within the patient's heart. In thecompressed configuration shown in FIG. 9A, the prosthesis 100 has a lowprofile retained as such by a delivery capsule or sheath 900 thattogether are suitable for delivery through small-diameter guidecatheters (not shown) positioned in the heart via antegrade orretrograde approaches. As used herein, “expanded configuration” refersto the configuration of the prosthesis 100 when allowed to freely expandto an unrestrained size without the presence of constraining ordistorting forces. “Deployed configuration,” as used herein, refers tothe prosthesis 100 once expanded at the native valve site (e.g., subjectto the constraining and distorting forces exerted by the native anatomy)and once the inflow member 140 has been expanded with the wire(s) 160.

FIGS. 9B and 9C illustrate steps in the process of deploying theprosthesis 100 (e.g., such as at a native valve location). Duringdeployment, the delivery sheath 900 is retracted proximally (arrow A6),first exposing the inflow member 140 within a first heart chamber orstructure (e.g., the left ventricle) (FIG. 9B). Upon exposure of theinflow member 140 to the heart, the delivery sheath 900 is retractedfurther proximally releasing the first end 122 of the anchoringstructure 120 (FIG. 9C). As shown in FIG. 9C, the wire 160 (see, e.g.,FIG. 5A) is moved distally and within the longitudinal andcircumferential segments 442, 444 of the channel 146 to expand inflowmember 140, and in some embodiments, the inflow member is at leastpartially expanded and/or positioned prior to releasing the second end124 of the anchoring structure 120 and allowing the anchoring structureto deploy and apply radial force against the native tissue. Once thedelivery sheath 900 is fully retracted from the prosthesis 100, theprosthesis can remain in the deployed configuration (FIGS. 3 and 4). Incertain embodiments, the delivery sheath 900 can reengage the prosthesisthereby transitioning the prosthesis from the deployed configuration tothe delivery configuration (shown in FIG. 9A).

FIGS. 10-11B illustrate one embodiment of a delivery system 1000suitable for delivery of the heart valve prostheses disclosed herein. Asused in reference to the delivery system, “distal” refers to a positionhaving a distance farther from a handle of the delivery system 1000along the longitudinal axis of the delivery system 1000, and “proximal”refers to a position having a distance closer to the handle of thedelivery system 1000 along the longitudinal axis of the delivery system1000.

FIG. 10 is side partial cut-away view of one embodiment of the deliverysystem 1000 which may be used to deliver and deploy embodiments of theheart valve prosthesis 100 disclosed herein through the vasculature andto the heart of a patient. The delivery system 1000 may optionallyinclude a guide catheter 1010 having a handle 1100 coupled to a deliveryshaft 1012, which in some embodiments is 34 F or less in diameter. Theguide catheter 1010 may be steerable or pre-shaped in a configurationsuitable for the particular approach to the target native valve. Adelivery catheter 1014 is slideably disposed within the guide catheter1010 and includes a flexible tubular outer shaft 1016 that extends to adelivery sheath 1018 (e.g., delivery sheath 900 of FIGS. 9A-9C) at adistal end thereof. During advancement to a treatment site, theprosthesis 100 is positioned in a compressed or delivery configurationwithin the delivery sheath 1018 as described above. A flexible innershaft 1020 is positioned slideably within outer shaft 1016 and extendsat least partially through the prosthesis 100. The prosthesis 100 iscoupled to the inner shaft 1020 and is releasable from the inner shaft1020 by release wires (not shown) that are configured to engage, forexample, the coupling features 125 (FIG. 4) on the frame 110 of theprosthesis 100. Additionally, the engagement tube 750 and ratchet tube740 extend through the inner shaft 1020 (illustrated in FIG. 11A anddiscussed further herein) to engage the ratcheting mechanism 710 securedwithin the anchoring structure 120 of the prosthesis 100. In theembodiment of FIG. 11 and with reference to FIG. 11A, the deliverysheath 1018 may further include a guidewire lumen 1019 attached orformed along only a distal length of the delivery sheath 1018 throughwhich a guidewire (not shown) may be slideably positioned, such that thedelivery sheath 1018 may be tracked through the vasculature in arapid-exchange manner. In other embodiments in accordance herewith,other guidewire lumens are contemplated such as one that extends thelength of the delivery system such that the delivery sheath and/or othercatheter thereof may be used in an over-the-wire manner. The deliverysheath 1018 can protect and secure the prosthesis 100 in its compressedconfiguration during delivery (FIG. 9A). The delivery catheter 1014 iscoupled to a plurality of actuator mechanisms 1130 (shown individuallyas 1130 a-1130 c) on the handle 1100 of the delivery catheter 1014.

FIG. 11A is an enlarged sectional view of the portion A and FIG. 11B isan enlarged sectional view of the portion B of the delivery system 1000shown in FIG. 10 and in accordance with an embodiment of the presenttechnology. FIG. 11A shows the distal end of the delivery catheter 1014with the delivery sheath 1018 cut away to illustrate the coupling of theengagement tube 750 and ratchet tube 740 extending through and from theinner shaft 1020 to the ratcheting mechanism 710 secured within theanchoring structure 120 of the prosthesis 100. Operatively, the deliverysheath 1018 may be retracted relative to the prosthesis 100 to permitexpansion of the prosthesis 100 while the inner shaft 1020 maintains thelongitudinal position of the prosthesis 100 relative to the anatomy. Theratchet tube 740 and engagement tube 750 may be nested and extendproximally to the handle 1100, for example, within a designated lumen ofthe inner shaft 1020.

FIG. 11B shows a cross-section view of the handle portion 1100 of thedelivery system including the actuator mechanisms 1130 which areconfigured to control one or more of the delivery elements at the distalend (FIG. 11A) of the delivery catheter 1014. Referring to FIGS. 11A and11B together, the handle 1100 includes a first actuator mechanism 1130 asuitable to control the advancement and retraction of the deliverysheath 1018. For example, during delivery of the prosthesis 100, theoperator can engage the first actuator mechanism 1130 a to beginretraction of the delivery sheath 1018 from the prosthesis 100 in stepsas described previously with respect to FIGS. 9A-9C. In this way, theouter shaft 1016 may be retracted relative to the inner shaft 1020 torelease (e.g., deploy) the prosthesis 100 from the delivery sheath 1018.

Referring to FIGS. 11A and 11B together, the handle 1100 also includes asecond actuator mechanism 1130 b configured to control advancement(distally) and retraction (proximally) of the engagement tube 750 withinthe inner shaft 1020 of the delivery catheter 1014. The handle 1100further includes a third actuator mechanism 1130 c configured to controladvancement (distally) and retraction (proximally) of the ratchet tube740 within the inner shaft 1020 of the delivery catheter 1014. Together,the second and third actuator mechanisms 1130 b, 1130 c can be used toengage the ratcheting mechanism 710 with the engagement tube 750 asshown in FIGS. 8A-8D. For example, the second actuator mechanism 1130 bcan be used to operatively move the engagement tube 750 such theopposing engagement levers 752 a, 752 b are aligned with indentation 724of the ratchet member 720. The third actuator mechanism 1130 c can thenbe used to operatively advance the ratchet tube 740 over the opposingengagement levers 752 a, 752 b to bias them to engage the indentation724 (FIGS. 8A and 8B). Then, the second and third actuator mechanisms1130 b, 1130 c can be used to advance the ratchet member 720 distallythereby translating distal movement of the wire 160 within the channel146 of the inflow member 140 (FIG. 9C). Once the inflow member 140 issuitably expanded, the second and third actuator mechanisms 1130 b, 1130c can be operated to disengage the engagement tube 750 from theratcheting mechanism 710 secured within the prosthesis 100 by retractingthese components proximally through the inner shaft 1020.

Various actuator mechanisms 1130 can be used, such as anaxially-slidable lever, a rotatable rack and pinion gear, or other knownmechanisms. In certain embodiments, a suitable mechanism (not shown) onthe handle 1100 can allow the operator to manage release wires (notshown) configured to couple the prosthesis 100 to the delivery catheter1014 via the coupling features 125. Once deployed, the suitablemechanism can be engaged to retract the release wires in a proximaldirection until they are disengaged from the coupling features 125.Following device deployment, the delivery catheter 1014 and guidecatheter 1012 can be retracted through the vasculature and removed fromthe patient.

Image guidance, e.g., intracardiac echocardiography (ICE), fluoroscopy,computed tomography (CT), intravascular ultrasound (IVUS), opticalcoherence tomography (OCT), or another suitable guidance modality, orcombination thereof, may be used to aid the clinician's positioning andmanipulation of the prosthesis 100 at the target native valve region. Insome embodiments, image guidance components (e.g., IVUS, OCT) can becoupled to the distal portion of the delivery catheter 1014, guidecatheter 1010, or both to provide three-dimensional images of thevasculature proximate to the target heart valve region to facilitatepositioning and/or deployment of the prosthesis 100 within the heartvalve region.

FIG. 12 is block diagram illustrating a method 1200 for repairing orreplacing a heart valve of a patient with the heart valve prosthesis 100described above with reference to FIGS. 3-11B and in accordance with anembodiment of the present technology. Referring to FIG. 12 (and withadditional reference to FIGS. 3-11B), the method 1200 can includepositioning a heart valve prosthesis 100 having a compressedconfiguration within a native heart valve region of the patient (block1202). The method 1200 can also include releasing the prosthesis 100 toat least partially expand (block 1204). In one embodiment, theprosthesis 100 can at least partially expand when a delivery sheath 1018is retracted, thereby removing the radially inward constraint on theprosthesis. The prosthesis 100 may be positioned such that an inflowmember 140 extends through an annulus of the heart valve (e.g., theaortic valve).

The method 1200 can further include at least partially advancing a wire160 within a channel 146 of the inflow member 140 to transition theinflow member 140 into a deployed (e.g., radially expanded)configuration (block 1206). In one embodiment, the wire 160 (orplurality of wires) can be advanced with operation of a lockingmechanism 170, such as a ratcheting mechanism 710, secured within alumen 121 of the prosthesis 100. For example, when using a ratchetingmechanism 710 as described herein, the wire 160 can be advancedincrementally (e.g., in either large, small, or a combination of largeand small increments). In certain embodiments, the advancement of thewire 160 using the locking mechanism 170 can be reversed such that thewire 160 is retracted, for example, to adjust radial expansion of theinflow member 140, reposition the prosthesis 100, or remove theprosthesis 100 from the patient's heart 10. In alternative embodiments,the wire 160 may be advanced through use of an actuator mechanism 1130disposed on the handle 1100 of the guide catheter 1010.

The method 1200 can still further include locking a position of the wire160 when the deployed configuration of the inflow member 140 is achieved(block 1208). In one embodiment, locking the wire 160 includesinhibiting slippage or retraction of the wire 160 proximally, therebypreventing collapse of the inflow member 140. In a particularembodiment, the locking mechanism 170 (e.g., the ratcheting mechanism710) can be configured to temporarily, permanently, or reversibly lockthe position of the wire 160 at a desired level of advancement thatexpands the inflow member 140 in a manner that allows the inflow member140 to adequately engage the native tissue to inhibit paravalvularleakage between the prosthesis 100 and the region of implantation (e.g.,native heart valve region, previously implanted prosthetic heart valvedevice or stent, etc.). When the inflow member 140 is deployed, themethod 1200 may continue with releasing remaining portions of theprosthesis 100, such as the anchoring structure 120, to self-expand orotherwise deploy (if not yet completed) and/or disengaging theprosthesis from the delivery system 1000 (block 1210). The prosthesis100 may be positioned such that the anchoring structure 120 of the frame110 is in a subannular position and will provide radial force outwardagainst a wall of the native heart valve region when in the deployedconfiguration. In a particular example, the anchoring structure 120 canbe in a region of the ascending aorta downstream of the sinotubularjunction.

Additional Embodiments

Features of the heart valve prosthesis and delivery system componentsdescribed above and illustrated in FIGS. 3-11B can be modified to formadditional embodiments configured in accordance with the presenttechnology. For example, the delivery system 1000 can provide deliveryof any of the heart valve prosthesis 100 illustrated in FIGS. 3-9C usingone or more additional delivery elements such as straightening sheathsand/or guide wires controllable, for example, using the handle 1100.Similarly, the heart valve prosthesis described above and illustrated inFIGS. 3-9C showing only a single wire 160 or locking mechanism 170 canalso include additional wires and similar or different lockingmechanisms positioned within the prosthesis 100 or, alternatively,within the handle 1100. Additionally, while the heart valve prosthesis100 described above shows a single flexible inflow member housing theprosthetic valve component 150, it will be understood that theprosthesis 100 can include additional support structures (e.g.cylindrical support structures) for housing the prosthetic valvecomponent 150 within or downstream of the inflow member 140.

Various method steps described above for delivery and deployment of theheart valve prosthesis for repairing or replacing a heart valve of apatient also can be interchanged to form additional embodiments of thepresent technology. For example, while the method steps described aboveare presented in a given order, alternative embodiments may performsteps in a different order. The various embodiments described herein mayalso be combined to provide further embodiments.

While various embodiments have been described above, it should beunderstood that they have been presented only as illustrations andexamples of the present technology, and not by way of limitation. Itwill be apparent to persons skilled in the relevant art that variouschanges in form and detail can be made therein without departing fromthe spirit and scope of the present technology. Thus, the breadth andscope of the present technology should not be limited by any of theabove-described embodiments, but should be defined only in accordancewith the appended claims and their equivalents. It will also beunderstood that each feature of each embodiment discussed herein, and ofeach reference cited herein, can be used in combination with thefeatures of any other embodiment. All patents and publications discussedherein are incorporated by reference herein in their entirety.

What is claimed is:
 1. A heart valve prosthesis for implantation at anative valve region of a heart, the prosthesis comprising: an expandableframe defining a lumen through which blood may flow, the lumen extendingfrom a first end to a second end thereof, wherein the frame includes aplurality of commissure posts extending from the first end; an inflowmember attached to the plurality of commissure posts, the inflow memberhaving an upstream portion and a downstream portion and a channel formedin a wall thereof, wherein the channel extends from at least thedownstream portion to the upstream portion, and wherein an interior ofthe inflow member is configured to support a prosthetic valve; a lockingmechanism secured within the lumen of the expandable frame; and a wireoperably coupled to the locking mechanism, the wire being at leastpartially slideably disposed within the channel of the inflow member,wherein the locking mechanism is configured to permit the wire to beadvanced within the channel of the inflow member to thereby transitionthe inflow member into a deployed configuration.
 2. The heart valveprosthesis of claim 1, wherein the inflow member is configured toinhibit paravalvular leakage between native anatomy of the heart and theheart valve prosthesis.
 3. The heart valve prosthesis of claim 1,wherein the inflow member comprises a flexible sheet having opposinginner and outer layers that form the wall of the inflow member andbetween which the channel is defined.
 4. The heart valve prosthesis ofclaim 3, wherein the channel includes a circumferential segment that atleast partially surrounds an opening of the inflow member at theupstream portion.
 5. The heart valve prosthesis of claim 3, wherein afold of the flexible sheet extends between the inner and outer layers,and the fold encircles the opening at the upstream portion of the inflowmember to define at least a portion of the circumferential segment ofthe channel.
 6. The heart valve prosthesis of claim 4, wherein thechannel includes a longitudinal segment that extends from thecircumferential segment to the downstream portion of the inflow member.7. The heart valve prosthesis of claim 6, wherein the wire extends fromthe locking mechanism through the longitudinal segment and at leastpartially through the circumferential segment of the channel, andwherein a first end of the wire is coupled to the locking mechanism anda second end of the wire is secured within the circumferential segment.8. The heart valve prosthesis of claim 6, wherein the wire has first andsecond wire ends coupled to the locking mechanism, and wherein a portionof the wire between the first and second ends is slidably disposedwithin the longitudinal and circumferential segments to form a loop. 9.The heart valve prosthesis of claim 8, wherein a radius of the loop isconfigured to increase or decrease by advancing or retracting at leastone of the first or second wire ends.
 10. The heart valve prosthesis ofclaim 1, wherein the locking mechanism is a ratcheting mechanism thatcomprises a housing with opposing pawls extending from a distal endthereof, and a ratchet member slidably disposed within the housing,wherein the ratchet member has a plurality of circumferentialindentations longitudinally spaced along a length thereof thatindividually interact with the opposing pawls of the housing to permitlinear movement of the ratchet member relative to the housing in only afirst direction.
 11. The heart valve prosthesis of claim 10, wherein thewire is coupled to the ratchet member to be translatable therewith. 12.The heart valve prosthesis of claim 11, wherein a length of the wireextending within the channel of the inflow member may be incrementallyincreased by sequentially engaging the opposing pawls of the housingwith each of the plurality of circumferential indentations as theratchet member is moved in the first direction relative to the housing.13. The heart valve prosthesis of claim 10, wherein the ratchetingmechanism is configured to permit the ratchet member to be retractedrelative to the housing in order to at least partially retract the wirefrom the channel of the inflow member to thereby transition the inflowmember into a reduced-diameter configuration.
 14. The heart valveprosthesis of claim 13, wherein the ratcheting mechanism furtherincludes a ratchet tube slideably disposed between the ratchet memberand the housing, and wherein the ratchet member is configured to beretracted relative to the housing when the ratchet tube is advanced to aposition between the opposing pawls and the ratchet member such that theopposing pawls are disengaged from the circumferential indentations. 15.A system for repair or replacement of a heart valve, the systemcomprising: a prosthetic heart valve comprising an anchoring structure;an inflow member coupled to and extending from the anchoring structure,the inflow member defining a lumen from an inflow end to an outflow endthereof and having a channel within a wall thereof; a prosthetic valvecomponent disposed within the lumen of the inflow member, the prostheticvalve component configured to inhibit retrograde blood flow through thelumen; an elongated stiffening element at least partially disposedwithin the channel of the inflow member to thereby transition the inflowmember and the prosthetic valve component into a deployed configuration;and a reversible ratcheting mechanism secured to the anchoring structureand coupled to the stiffening element; and a catheter assemblyconfigured to deliver and deploy the prosthetic heart valve, thecatheter assembly comprising a handle assembly having a first actuatorfor operating the reversible ratcheting mechanism to advance thestiffening element within the channel of the inflow member; and anengagement tube extending from the handle assembly, the engagement tubeconfigured to operatively engage the reversible ratcheting mechanism ata proximal end thereof upon actuation of the first actuator.
 16. Thesystem of claim 15, wherein the reversible ratcheting mechanismcomprises: a ratchet housing secured to the anchoring structure, theratchet housing having opposing first and second pawls extending from adistal end thereof; and a ratchet member coupled to the stiffeningelement, the ratchet member slidably disposed within the ratchethousing, wherein the ratchet member has a plurality of circumferentialindentations longitudinally spaced along a length thereof thatindividually interact with the first and second pawls of the ratchethousing to permit linear movement of the ratchet member relative to theratchet housing in a first direction when engaged by the engagement tubeupon actuation of the first actuator, wherein a length of the stiffeningelement extending within the channel of the inflow member may beincrementally increased by sequentially engaging the opposing first andsecond pawls of the ratchet housing with each of the plurality ofcircumferential indentations as the ratchet member is moved in the firstdirection relative to the ratchet housing.
 17. The system of claim 15,wherein the reversible ratcheting mechanism comprises: a ratchet membercoupled to the stiffening element; a ratchet housing having opposingpawls extending from a distal end thereof and configured toincrementally engage the ratchet member; and a ratchet tube slidablydisposed between the ratchet member and the ratchet housing to inhibitengagement of the pawls with the ratchet member when in an advancedposition.
 18. The system of claim 17, wherein the handle assemblyfurther comprises a second actuator operable for retracting the ratchettube such that the pawls engage the ratchet member.
 19. The system ofclaim 18, wherein the second actuator is configured to advance theratchet tube to disengage the pawls from the ratchet member, and whereinthe first actuator is configured to retract the ratchet member via theengagement tube to thereby transition the inflow member and theprosthetic valve component into a reduced-diameter configuration. 20.The system of claim 15, wherein the stiffening element is configured tobe at least partially retracted from the channel of the inflow member tothereby transition the inflow member and the prosthetic valve componentinto a reduced-diameter configuration.
 21. The system of claim 15,wherein the prosthetic heart valve further comprises a plurality ofcommissure posts extending from the anchoring structure, and wherein theinflow member comprises a sheet of flexible material coupled to thecommissure posts.
 22. The system of claim 15, wherein the stiffeningelement at least partially disposed within the channel of the inflowmember is structurally independent of the anchoring structure, andwherein the stiffening element is radially deformable withoutsubstantially deforming the anchoring structure.
 23. The system of claim15, wherein the stiffening element extends from the ratcheting mechanismthrough the channel to form a loop.
 24. The system of claim 15, whereina first end of the stiffening element is coupled to the ratchetingmechanism and a second end of the stiffening element is secured withinthe channel.
 25. The system of claim 15, wherein the inflow membercomprises a folded sheet of flexible material that forms opposing innerand outer layers of the wall of the inflow member between which thechannel is defined.
 26. The system of claim 25, wherein the channelincludes a circumferential segment that at least partially surrounds anopening of the lumen at the inflow end of the inflow member.
 27. Amethod of repairing or replacing a heart valve in a patient, the methodcomprising: positioning a prosthetic device in a compressedconfiguration within a heart valve region of the patient; releasing theprosthetic device to at least partially expand such that an inflowmember extends through an annulus of the heart valve; at least partiallyadvancing a wire within a channel of the inflow member to transition theinflow member into a deployed configuration; and locking a position ofthe wire when the inflow member is in the deployed configuration. 28.The method of claim 27, wherein at least partially advancing the wirecomprises incrementally advancing the wire using a ratcheting mechanism.29. The method of claim 27, wherein releasing the prosthetic device toat least partially expand includes retracting a delivery sheath from atleast a distal portion of the prosthetic device.
 30. The method of claim27, further comprising: releasing an anchoring structure of theprosthetic device to self-expand within a subannular region of the heartvalve.